Trial Information

Quality of Life in Younger Breast Cancer Survivors

OBJECTIVES:

- Compare the quality of life (physical functioning, psychological functioning, social
functioning, and spiritual functioning) of female breast cancer survivors who were age
45 or younger at the time of diagnosis with the quality of life of female breast cancer
survivors who were age 55 to 70 at time of diagnosis (considering type of surgical
treatment [lumpectomy vs mastectomy], hormonal treatments, and time since diagnosis as
covariates) and age-matched (to the younger group) females with no history of breast
cancer.

- Compare the quality of life (physical functioning, psychological functioning, social
functioning, and spiritual functioning) of partners of breast cancer survivors who were
age 45 or younger at time of diagnosis with the quality of life of partners of breast
cancer survivors who were age 55 to 70 at diagnosis and partners of age-matched (to the
younger group) females with no history of breast cancer.

- Test and compare quality of life models that identify the variables that mediate
between antecedent variables of personal characteristics, diagnostic and treatment
characteristics, and quality of life outcomes in order to determine where interventions
to improve quality of life should be targeted.

- Explore the relationship of partner antecedent, mediating, and outcome variables as
predictors or mediators of outcome variables for breast cancer survivors.

OUTLINE: This is a multicenter study.

Patients, spouse or partner of patients, age-matched acquaintances of patients, and partner
of acquaintances complete questionnaires over 60-90 minutes about personal characteristics,
self-efficacy, coping, social support, health care provider communication, physical,
psychological, social, and spiritual functioning, and quality of life. After completing the
study questionnaires, patients and age-matched acquaintances of patients are interviewed via
telephone over 30 minutes for cognitive function assessment. A random subset of patients and
spouses/partners of patients are interviewed via telephone over 45-60 minutes, using
data-generating and open-ended questions, regarding physical functioning, sexual and
reproductive issues, psychological issues, social impact, and methods used to deal with
breast cancer survivor concerns.

Disease and treatment characteristics of patients are obtained from medical records.

PROJECTED ACCRUAL: A total of 2,697 patients, spouse or partner of patients, age-matched
female acquaintances of patients, and partner of acquaintances will be accrued for this
study.

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Patient

- Female breast cancer survivor with age at initial diagnosis in 1 of the
following ranges:

- 18 to 45

- 55 to 78

- Must have enrolled and participated in ECOG study CLB-9741, E-1199, or E-2197

- Must have received chemotherapy at least 3 years, but no more than 8 years prior
to this study entry

- Disease free at the time of this study entry

- Spouse or partner of the patient, age-matched female acquaintances of the patient (in
the younger patient group), or partner of acquaintances

- Spouse or partner of the patient may be either gender

- Age-matched female acquaintance is defined as within 5 years of age difference
of the patient in younger group (18-45 years of age)

- With a similar level of education and race of the patient

- Not a personal friend of the patient

- No history of breast cancer

PATIENT CHARACTERISTICS:

- Must reside in the continental U.S. and speak English (for patients)

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Comparison of the quality of life

Safety Issue:

No

Principal Investigator

Victoria Champion, DNS

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000460234

NCT ID:

NCT00309933

Start Date:

October 2005

Completion Date:

Related Keywords:

Breast Cancer

Cancer Survivor

Cognitive/Functional Effects

Psychosocial Effects of Cancer and Its Treatment

Sexuality and Reproductive Issues

Spiritual Concerns

cognitive/functional effects

spiritual concerns

sexuality and reproductive issues

psychosocial effects of cancer and its treatment

cancer survivor

stage I breast cancer

stage II breast cancer

stage IIIA breast cancer

stage IIIB breast cancer

stage IIIC breast cancer

Breast Neoplasms

Name

Location

Suburban Hospital

Bethesda, Maryland 20814

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois 60521

Mercy Medical Center - Sioux City

Sioux City, Iowa 51104

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa 51101

St. Luke's Regional Medical Center

Sioux City, Iowa 51104

Bronson Methodist Hospital

Kalamazoo, Michigan 49007

West Michigan Cancer Center

Kalamazoo, Michigan 49007-3731

Borgess Medical Center

Kalamazooaa, Michigan 49001

Duluth Clinic Cancer Center - Duluth

Duluth, Minnesota 55805-1983

CCOP - Duluth

Duluth, Minnesota 55805

Miller - Dwan Medical Center

Duluth, Minnesota 55805

Mercy Cancer Center at Mercy Medical Center

Canton, Ohio 44708

MetroHealth Cancer Care Center at MetroHealth Medical Center

Cleveland, Ohio 44109

Sanford Cancer Center at Sanford USD Medical Center

Sioux Falls, South Dakota 57117-5039

Medical X-Ray Center, PC

Sioux Falls, South Dakota 57105

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin 54449

Marshfield Clinic - Indianhead Center

Rice Lake, Wisconsin 54868

Memorial Hospital of South Bend

South Bend, Indiana 46601

Rush University Medical Center

Chicago, Illinois 60612-3824

CCOP - Northern Indiana CR Consortium

South Bend, Indiana 46601

Saint Joseph Regional Medical Center

South Bend, Indiana 46617

CCOP - Scott and White Hospital

Temple, Texas 76508

St. Vincent Mercy Medical Center

Toledo, Ohio 43608

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey 08690

CCOP - Toledo Community Hospital

Toledo, Ohio 43623-3456

Waukesha Memorial Hospital Regional Cancer Center

Waukesha, Wisconsin 53188

Medical University of Ohio Cancer Center

Toledo, Ohio 43614

Toledo Hospital

Toledo, Ohio 43606

Mary Babb Randolph Cancer Center at West Virginia University Hospitals

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